MDSS Consulting GmbH

MDSS Consulting GmbH offers expert regulatory consulting for medical devices and IVDs, specializing in EUDAMED onboarding and compliance. They provide comprehensive support for registration and ongoing management.

MDSS Consulting GmbH is a specialized consultancy focused on regulatory affairs for medical devices and In Vitro Diagnostic (IVD) products. They offer extensive expertise in navigating complex regulatory landscapes, with a particular emphasis on EUDAMED compliance and onboarding. Their services include guidance on EUDAMED registration for various roles, product registration, and managing updates within the database. They assist clients in understanding the requirements for SRN numbers, actor registration, and timely reporting of product information. MDSS Consulting GmbH provides tailored support, from initial consultations to full outsourcing of EUDAMED-related tasks. They aim to simplify the often daunting process of regulatory compliance, ensuring clients can bring their products to market efficiently and safely. Their team is dedicated to providing clear, actionable advice and practical solutions for manufacturers and authorized representatives.

Key Highlights

  • MDSS Consulting GmbH specializes in EUDAMED onboarding and compliance for medical devices and IVDs. Source
    “MDSS Consulting GmbH offers expert regulatory consulting for medical devices and IVDs, specializing in EUDAMED onboarding and compliance.”
  • They provide support for obtaining EUDAMED registration numbers (SRN) for various roles. Source
    “benötigen für jede Rolle eine eigene EUDAMED Registriernummer (SRN) im Akteur-Modul”
  • The company offers interactive support via MS Teams/Zoom for EUDAMED-related tasks. Source
    “Interaktive Unterstützung via MS Teams/Zoom bei”
  • MDSS Consulting GmbH facilitates partial or full outsourcing of EUDAMED registration tasks. Source
    “Partielle/vollständige Auslagerung an unser Team für”
  • They offer a free initial consultation for regulatory needs. Source
    “Request a free initial consultation*.”

Certifications & Trust Signals

  • MDSS Consulting GmbH is based in Hannover, Germany. Source
    “Schiffgraben 4130175 HannoverGermany”

Buyer Snapshot

Best for
  • Companies needing expert guidance on EUDAMED registration and compliance.
  • Manufacturers of medical devices and IVDs requiring support with UDI device registration.
  • Organizations seeking to outsource complex regulatory tasks.
How engagement typically works
  • Interactive support via MS Teams/Zoom.
  • Partial or full outsourcing of EUDAMED tasks.
  • Free initial consultation (30-minute call, online meeting, or in-person meeting).
Typical deliverables
  • EUDAMED Actor Registration (SRN) support.
  • UDI Device registration guidance.
  • Regulatory strategy development.
  • Assistance with database updates and changes.
Good to know
  • Best when requiring specialized knowledge of EUDAMED regulations for medical devices and IVDs.

Pricing

Model: Custom pricing
HQ: Hannover, Germany
Languages: English, German
Timezones: UTC+1
Claim status: Listed

Services & Capabilities

EUDAMED Onboarding & Data Registration Support (Mandatory Modules)

Modules Supported: Actor/SRN, UDI/Devices
Submission Approach: Portal, M2M Integration
Managed Service Available: Yes
Integration Support: ERP/PLM mapping

Additional eudamed_onboarding_support Details

Modules Supported
Actor/SRN, UDI/Devices
Submission Approach
Portal operations, interactive support
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